Shionogi receives approval to develop and commercialize intravenous peramivir in Japan

BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that its partner, Shionogi & Co., Ltd. has received marketing and manufacturing approval for intravenous (i.v.) peramivir to treat patients with influenza in Japan.  Shionogi intends to commercially launch peramivir under the commercial name RAPIACTA in Japan, pending the product's National Health Insurance (NHI) price listing.

As a result of this approval, BioCryst will receive a third and final regulatory milestone payment of $7 million under its license agreement with Shionogi.  BioCryst may receive future commercial event milestone payments of up to $95 million from Shionogi.

"This first approval of a BioCryst discovered drug is a major step in our journey towards building an enduring and successful biopharmaceutical company," said Jon P. Stonehouse, President and Chief Executive Officer of BioCryst.  "We congratulate Shionogi on receiving rapid approval of peramivir, one of the quickest marketing authorizations ever granted by the Japanese authorities.  BioCryst continues to work with other governments and our partners to make i.v. peramivir available as a treatment option for hospitalized patients with influenza during the ongoing pandemic, and to complete the development of peramivir as a seasonal influenza treatment in the future."

Shionogi received the indications of single dose administration of 300 mg i.v. peramivir for adult uncomplicated seasonal influenza infection, as well as single and multiple dose administration of 600 mg i.v. peramivir for the patients at high-risk for complications associated with influenza.  Shionogi is authorized to supply peramivir as either a 300 mg i.v. bag or a 150 mg vial for i.v. drip infusion.

Additionally, Shionogi announced that it has completed clinical studies for pediatric patients and the Company will make its best efforts to file an additional application for pediatric use of RAPIACTA within its current fiscal year, which ends March 31, 2010.